Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations

NCT03512795 | Completed

• 1 other identifier: BLOT AOI 2017
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult when the viral load is undetectable or during therapeutic breaks. In these situations, the ultra-deep sequencing (UDS) can be done on proviral DNA in order to improve characterization of archived resistant variants with may reflect past virological failures. This study is a cross-sectional study which will require only one additional tube which can be taken during a routine check-up as part of the usual follow-up of the individuals included.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• > Genotyping Score (GSS) comparison between HIV DNA-UDS genotyping assay obtained at inclusion and cumulative RNA-Sanger genotyping assays obtained at each virological failure during routine follow

  baseline

Interventions

Blood samples BIOLOGICAL

An additional blood tube will be taken during the patient's follow-up blood collection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients living with HIV-1, with an undetectable viral load and a history of at least 2 virological failures in which resistance to at least two drug classes was observed

You may qualify if:

• Patient who has given consent
• Adult patient
• Patient living with HIV-1
• Controlled viral load (\<50 RNA copies/ml) for at least 1 year.
• At least two previous virologic failures, either :
• Initial failure : defined as the persistence of a viral load greater than 50 copies/ml beyond 1 year, after the initiation of triple antiretroviral therapy, and without virological control (VL \> 50 copies/ml) since the initiation of the very first antiretroviral treatment.
• A rebound in HIV viral load to more than 50 copies/ml after a period of virological success, confirmed on two consecutive samples at least one month apart.
• At least 2 Sanger RNA genotypes have been done or could be done from the existing library.

You may not qualify if:

• Patient not affiliated to a medical insurance scheme
• Protected adult
• Pregnant, parturient or breastfeeding woman
• Discontinuation of clinical and immuno-virological follow-up for more than 2 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: August 8, 2018
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

FR (1)